Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000948
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : February 4, 2013
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system.

IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Aldesleukin Drug: ART Phase 2

Detailed Description:

Interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in an increased CD4+ cell count that might impact upon HIV disease progression. A Phase III trial involving large numbers of HIV-positive patients is the next step in the development process. To develop appropriate clinical experience with this combination, this Phase II trial will allow administration of IL-2 plus antiretroviral therapy to a small number of patients in sites being considered for the Phase III trial.

Patients receive antiretrovirals alone or antiretrovirals plus IL-2 given subcutaneously. Three doses of IL-2 are studied, with 12 patients evaluated at each dose. When at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicity, the next 12 patients are treated at the next highest dose every 12 hours for 5 days every 8 weeks; when this dose is tolerated, the last 12 patients randomized receive the highest study dose every 12 hours for 5 days every 8 weeks. Patients enrolled at the first two doses of IL-2 who complete three courses of treatment have their dose escalated to a maximum of the highest study dose.

Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Phase II Study of Subcutaneous Interleukin-2 (Proleukin) Plus Antiretroviral Therapy vs. Antiretroviral Therapy Alone in Patients With HIV Infection and at Least 350 CD4+ Cells/mm3
Study Start Date : February 1998
Actual Primary Completion Date : March 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Aldesleukin

Arm Intervention/treatment
Experimental: 1
Participants will be broken into 3 groups. Each group will receive ART and escalating doses of aldesleukin. All participants will then receive that maximum tolerated dose of aldesleukin.
Drug: Aldesleukin

Drug: ART
antiretroviral therapy for the treatment of HIV

Active Comparator: 2
All participants will receive ART
Drug: ART
antiretroviral therapy for the treatment of HIV

Primary Outcome Measures :
  1. CD4 count [ Time Frame: Throughout study ]
  2. Laboratory and clinical adverse events [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a CD4 cell count greater than or equal to 300 cells/mm3.
  • Have no AIDS-defining illnesses.
  • Are at least 18 years old.
  • Have been on antiretroviral therapy for at least 7 days prior to study entry.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study.
  • Have a history of cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system abnormality, or an autoimmune/inflammatory disease.
  • Are pregnant or breast-feeding.
  • Have ever received IL-2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000948

Chulalongkorn Univ. Hosp. C603-010 CRS
Bangkok, Ratchathewi, Thailand
Siriraj Hospital C603-020 CRS
Bangkok, Ratchathewi, Thailand
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Kiat Ruxrungthum

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00000948     History of Changes
Other Study ID Numbers: IRP 021B
10465 ( Registry Identifier: DAIDS ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 2013

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Injections, Subcutaneous
Dose-Response Relationship, Drug
Drug Therapy, Combination
CD4 Lymphocyte Count
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents